Duns Number:008171162
Device Description: A concentrated wash or cleaning solution intended to be used as a consumable reagent on-bo A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
Catalog Number
-
Brand Name
Concentrated Washing Solution 3
Version/Model Number
79053
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQO
Product Code Name
Automated Urinalysis System
Public Device Record Key
58867e28-5be3-4f66-aabd-c6f22e3b7af5
Public Version Date
August 28, 2019
Public Version Number
1
DI Record Publish Date
August 20, 2019
Package DI Number
10015482790537
Quantity per Package
5
Contains DI Package
00015482790530
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |